Associate Global Study Manager

DOCS Global, an FSP Division of ICON Clinical, are working with a Global Biopharmaceutical company in building a large FSP team within a global clinical operations in Poland.

We are looking for experienced Lead CRAs, Principle CRAs, Local Trial Managers, Local Study Leads, Local Start-Up Leads or other candidates with previous study management experience to join our team.

SUMMARY OF THE ROLE
The Associate Global Study Manager (AGSM) will be supporting the Global PM in
the execution of clinical studies within Trial Operations.

The AGSM is responsible for:
• preparation of study related plans and materials,
• identification of study risks and contingency planning,
• vendor management and oversight
• appropriate escalation of issues,
• monitoring of the study planning and budget to ensure it is kept within budget

REQUIREMENTS:
• Bachelor or Master in (Bio)Medical Sciences, Chemistry, Pharmacology, Life Sciences or related study.
• Experience of working internationally
• Experience in coordinating vendors Demonstrated ability to work well both on a cross-functional team and independently
• Leadership/project management skills
• Previous CRA/on-site monitoring experience would be a plus

HOW TO APPLY
Please contact Dagmara Drozdowska, Recruitment Consultant at ICON FSP DOCS on 668 87 02 61 and email your up-to-date CV to: dagmara.drozdowska@docsglobal.com

RESPONSIBILITIES INCLUDE:

Study Budget.
• SPE Management. Grant plan request for all countries. Package shipment to local teams.
• Local Study Cost request (LSCR) Provide analytics to GSM at study level. Validate & track invoices. Final Budget reconciliation

Vendor Management:
• Initiate Vendor proposal & cost estimates. Set-up & conduct vendor meetings.
• Develop Vendor Budget proposal. Develop & update vendors specifications. Review technical vendor status reports. Escalate Vendor management issues. Review & Approval vendor invoices.

Quality:
• Review Audits Reports & Coordinate answers. Drive Deviation Process
• IMP Management: Check PTC tracker and if linked to AE- Check AE reported

Regulatory & Ethics:
• CTA package process- KOM, provide information for CTA application form. Insurance certificate/ Claim management.

Study Training:
• Develop & Maintain Global Study Training Materials. Organize/Conduct global
• F2F or virtual Investigator & Monitoring Meetings

Study Management:
• Prepare Study Status Report (SSR), lessons learned & Meeting Minutes.
• Monitor Subject Recruitment & Screening Closure

Protocol & ICF Development:
• Ensure Protocol, associated ICF documents, applicable
• Amendments & other essential documents are provided to the study team. Deliver & Maintain Study Compliance Form (SCF)

Study Plans/Docs
• Compile appendices Monitoring Plan
• Review Recruitment & Retention Plan, Central Monitoring Plan ,Data Validation Specifications, e-CRF/CCI, e-TMF Plan, EDL & Final Reconciliation
• Develop & Maintain Q&A log
• Set-up Study Enrolment plan in CTMS

Study Closure
• Oversight of Site Closure at a Global level, communicate Study closure to Local Study teams, reconcile & close-out vendor contracts. Close Out CTMS

If you are seeking an international company who is committed to development and training and the opportunity for career progression, please get in contact.

#PMjob